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BioMérieux Obtains CE Mark for VIDAS 3, Plans to Pursue US FDA Approval


BioMérieux said that its VIDAS 3 immunoassay platform has received an EU CE mark, making it commercially available in Europe and other countries recognizing the CE marking.

In a statement, François Lacoste, corporate vice president of BioMérieux's immunoassay unit, said the company now plans to pursue regulatory approval for the platform in other countries – the US and China, in particular.

The VIDAS 3 is the latest in BioMérieux's VIDAS line and, the company said, offers enhanced automation, improved traceability, and new software features, as well as a quality control program that is in compliance with laboratory certification standards.

Using the same reagents as previous VIDAS instruments, the device currently offers tests for 99 clinical parameters.

According to BioMérieux, the VIDAS line has the largest installed base of automated immunoassay systems in the world, with more than 27,000 instruments in clinical labs. The company claims that it has received roughly 200 intentions to purchase the new instrument based on recent conference demonstrations.